FDA 510(k)

婴儿光疗设备

K号: K210289 · 2021-05-28

决定日期2021-05-28

产品代码LBI

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Infant Phototherapy Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Bistos Co., Ltd.. It received FDA 510(k) clearance on 2021-05-28 under 510(k) number K210289. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Infant Phototherapy Equipment?

Infant Phototherapy Equipment is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K210289.

When did Infant Phototherapy Equipment receive FDA 510(k) clearance?

Infant Phototherapy Equipment received FDA 510(k) clearance on 2021-05-28, under 510(k) number K210289.

Who is the listed applicant for Infant Phototherapy Equipment?

The FDA 510(k) record lists Bistos Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infant Phototherapy Equipment?

The FDA product code for Infant Phototherapy Equipment is LBI.

列明Bistos Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251512Hi bebe super (BT-150B)K232991BT-1000 K200675Hi bebe super (Models BT-150S and BT-150L)K160274Hi bebe plus

官方来源

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